Mon.Nov 25, 2024

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Look out, Pfizer: BridgeBio scores 'best-case' FDA nod for Attruby in cardiomyopathy

Fierce Pharma

On a Zoom call last month from California, BridgeBio CEO Neil Kumar needled a colleague about the remote possibility of the New York Yankees rallying to win the World Series as they trailed the Los | The FDA has signed off on BridgeBio's Attruby (acoramidis), a potential blockbuster to treat patients with the rare heart disease transthyretin amyloid cardiomyopathy.

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The Case for a “Single Source of Truth” in Provider Credentialing

MedCity News

A single source for provider credentialing would involve creating a centralized, continuously updated database of credentialing information that could be accessed and trusted across the healthcare sector. While no such system exists today, it should be the goal, and here’s why. The post The Case for a “Single Source of Truth” in Provider Credentialing appeared first on MedCity News.

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Merck preps filings after blockbuster-in-waiting Winrevair succeeds in severe PAH study

Fierce Pharma

Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition. | In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair met its primary endpoint of time to first morbidity or mortality event, which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening in patients with PAH.

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Common MRF Mistakes Hospitals Are Making in 2024

MedCity News

Updated schema requirements are easy to mix up — here are a few simple solutions The post Common MRF Mistakes Hospitals Are Making in 2024 appeared first on MedCity News.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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ASH: Incyte's Monjuvi triumphs in follicular lymphoma phase 3, teeing up FDA filing

Fierce Pharma

Incyte’s previously disclosed phase 3 win in relapsed or refract | In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb's Revlimid and Roche's Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan.

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This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths

MedCity News

Endoscopy, the standard for detecting esophageal precancer, is quite an invasive procedure — so a lot of people who should be screened end up never being tested. Lucid Diagnostics is trying to solve this problem by selling a quick, office-based diagnostic. The post This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths appeared first on MedCity News.

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FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.

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AZ's Truqap delivers phase 3 win in prostate cancer subtype after recent breast cancer miss

Fierce Pharma

After a recent failed showing in a breast cancer subgroup raised doubts around AstraZeneca’s Truqap, the first-in-class AKT inhibitor is making inroads in a prostate cancer subtype. | The AKT inhibitor's early win in a prostate cancer subtype follows a recent surprise flop in a breast cancer study. AZ has been working to grow Truqap beyond its current limited approval in a niche breast cancer category.

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Cortica Snags $80M to Make Autism Care for Children Less Fragmented

MedCity News

Cortica’s $80 million raise was co-led by Morgan Health and Nexus NeuroTech Ventures and included participation from Autism Impact Fund. The post Cortica Snags $80M to Make Autism Care for Children Less Fragmented appeared first on MedCity News.

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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

PharmaVoice

A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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UK digital health funding should be ringfenced, says report

pharmaphorum

IT industry group techUK has called on the government to guarantee funding for digital transformation and cyber resilience in health and social care.

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Leveraging price transparency for margin improvement in health systems 

Clarify Health

The expectation to increase revenue and maintain sustainable profit margins is a constant drum for most health systems. Balancing the need for sustainable margins with the challenges of navigating complex payer contracts and regulatory demands is no easy feat. As health systems grapple with increasing pressure from payers, challenges in collecting and analyzing payer-negotiated rate data, and limited benchmarking capabilities, price transparency data emerges as a crucial tool for driving infor

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Relief for AZ as Truqap hits the spot in prostate cancer

pharmaphorum

After a disappointing result with Truqap in triple-negative breast cancer, AstraZeneca chalks up a win in prostate cancer.

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Peer Exchange: RFID Technological Obstacles (Episode 2)

Pharmaceutical Commerce

In the second part of this roundtable discussion, key opinion leaders discuss the potential technological challenges surrounding RFID, and the likelihood of not only utilizing this tech at the item level but for product security purposes as well.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Halozyme abandons its €2bn pursuit of Evotec

pharmaphorum

Halozyme Therapeutics has withdrawn its offer to acquire Evotec, saying that the German company had been unwilling to engage with negotiations.

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AI and automation to drive “substantial progress” in pharmaceutical analytical testing

European Pharmaceutical Review

The pharmaceutical analytical testing market is seeing significant growth following a greater incidence in the complexity of medicine development and higher demand for biologics and biosimilars, according to a report by Straits Research Pvt. Ltd. Their analysis projected that the market will exceed a value of $15.46 billion by 2032. The market is furthermore expected to see a compound annual growth rate (CAGR) of 7.3 percent between 2024 and 2032.

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FDA Expands Labelling for Roche’s Pathway Rabbit Monoclonal Primary Antibody in Patients with Biliary Tract Cancer

PharmExec

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

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GSK gains approval in Japan for extended indication of RSV vaccine

Pharmaceutical Technology

GSK has received approval from Japan's MHLW for its application to extend the indication of its RSV vaccine, Arexvy.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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BridgeBio poised to challenge Pfizer after Attruby approval

pharmaphorum

BridgeBio grabs FDA approval for its ATTR cardiomyopathy drug Attruby, setting up a challenge to market leader Pfizer

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Pharma Pulse 11/25/24: Deepening Patient Relationships,

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

Pharma 52
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Sustainability in biopharma: Collaboration and technology light the way forward

Pharmaceutical Technology

The biopharmaceutical industry is being called to take its sustainability efforts to the next level. A new report sheds light on the topic.

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Exact Sciences Enlists Carlos Ponce to Promote Early Cancer Screening

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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MSD’s WELIREG approved by NMPA to treat VHL disease-associated tumours

Pharmaceutical Technology

China’s NMPA has approved MSD’s WELIREG (belzutifan) to treat adult individuals with certain types of VHL disease-associated tumours.

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AbbVie Launches Allergan Aesthetics Learning Platform

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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GSK eyes up combo approval for previously withdrawn myeloma drug

Pharmaceutical Technology

The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

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GBI Biomanufacturing Grows Drug Product Services

Pharmaceutical Commerce

The CDMO’s offerings will now feature automated fill-finish.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Exploring drug shortages in European markets: the causes, analysis, and response

Pharmaceutical Technology

Since 2023, the pharmaceutical industry operating in Europe has faced an unprecedented challenge related to drug shortages.

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Pharma Pulse 11/25/24: Pharma Stilll Struggling with Digital Transformation, Removing Barriers to Gene Therapies & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Pharmaceutical Technology

The US FDA has approved BridgeBio Pharma’s Attruby (acoramidis) for treating adult individuals with ATTR-CM.

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Study Results Show 1 in 20 Adults With RSV Are Hospitalized

Pharmacy Times

Findings highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.